Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
NCT ID: NCT02932904
Last Updated: 2018-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
361 participants
INTERVENTIONAL
2016-11-21
2017-06-09
Brief Summary
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Detailed Description
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The study will enroll approximately 352 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vortioxetine 10 mg
* Vortioxetine 20 mg
* Paroxetine 20 mg
* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient
All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.
This multicenter trial will be conducted in United States. The overall time to participate in this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vortioxetine 10 mg
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Vortioxetine
Vortioxetine Overencapsulated Tablet
Vortioxetine 20 mg
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
Vortioxetine
Vortioxetine Overencapsulated Tablet
Paroxetine 20 mg
Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Paroxetine
Paroxetine Overencapsulated Tablets.
Placebo
Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.
Placebo
Vortioxetine Placebo-matching Capsules.
Interventions
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Vortioxetine
Vortioxetine Overencapsulated Tablet
Paroxetine
Paroxetine Overencapsulated Tablets.
Placebo
Vortioxetine Placebo-matching Capsules.
Eligibility Criteria
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Inclusion Criteria
2. Has a body mass index (BMI) of 18 to 35 kg/m\^2, inclusive, at the Screening and Baseline Visits.
3. If female, has a regular menstrual cycle.
4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score \>47 (men) or \>41 (women) at the Screening and Baseline Visits.
5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.
Exclusion Criteria
2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
5. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
6. Has a history of depression or any other psychiatric illness.
7. Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
9. Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
10. If female, has polycystic ovarian syndrome.
11. Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
18 Years
40 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Encino, California, United States
Long Beach, California, United States
Torrance, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Portland, Oregon, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1174-1779
Identifier Type: OTHER
Identifier Source: secondary_id
Vortioxetine-4001
Identifier Type: -
Identifier Source: org_study_id
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